Page 7 - GMP-PharmaCongress 2024

areas (materials, waste, environ- • Enclosed transfer of sterilized ceptible to human variability. Be-
mental samples) should be carried products via ports: Closed transfer cause the transfer of materials
out via a separate unidirectional systems for the transfer of already between Grade C and Grade A
process. […]” [1]. sterilized materials provide a high environments is most critical, other
• Double-Door Autoclave: A wall- level of sterility assurance. One op- options are preferable to meet EU
integrated autoclave is used for tion is a combination of auto- Annex 1 standards.
steam sterilization of equipment claving and closed transfer: Heat-
entering a clean or aseptic area. tolerant materials are autoclaved Functionality and use of
This method is not suitable for in special Beta containers and then an RDS
temperature sensitive materials. transferred to the Grade A area via
• Depyrogenation Tunnel: Hot air rapid transfer ports (RTP). This In the pharmaceutical industry, Ra-
sterilization and depyrogenation method is not suitable for tem- pid Decontamination Stations (RDS)
tunnels remove pyrogens from so- perature-sensitive materials. have emerged as a solution that
lutions or surfaces by controlled Another option is to transfer combines and optimizes the ap-
exposure to high temperatures. gamma-irradiated and ethylene- proach of decontamination hatches
This method is mainly used for oxide-sterilized disposables and and transfer via ports (fig. 1).
glass containers. single-use systems via single-use RDSs are designed to deconta-
• Rapid Decontamination Hatch beta containers. minate materials, using vapourised
(RDH) using vH 2 O 2 : Decontamina- • Transfer hatches with manual sur- hydrogen peroxide. These materials
tion pass boxes using vaporized face decontamination: Transfer include monitoring materials, clean-
hydrogen peroxide (vH 2 O 2 ) are a hatches with manual surface de- ing materials, tools, format parts,
versatile and efficient method of contamination involve the manual and spare parts. The materials must
decontaminating and transferring application of sporicidal agents be properly placed in the chamber
materials. Decontamination and constant laminar airflow. EU of the RDS, and the item-loading
chambers and hatches are GMP Annex 1 highlights the im- aspects must be considered during
designed to ensure EU GMP portance of material transfer, plac- material transfer qualification. The
Grade A/ISO 14644 class 5 clean- ing “an emphasis upon robust dis- effectiveness of hydrogen peroxide
liness levels. The decontamination infection/decontamination prac- vapours depends on both the overall
process is automated and qualified. tices where the use of autoclaves is concentration and the even distri-
When these chambers are used to not possible” [1]. Hence transfer bution of the hydrogen peroxide
transfer the materials into the fill- hatches rely on manual wiping and within the RDS chamber. Vapourised
ing isolator, they provide a high spraying techniques, they are sus- hydrogen peroxide cannot kill mi-
level of sterility assurance and
make full compliance to the con- Authors
tamination control strategy. The
decontamination hatches can be
used for a variety of materials but
are relatively slow, and outgassing
of materials can be a concern.
• Electron Beam Radiation
(E-Beam): E-Beam uses electron
beams for surface decontamina-
tion. E-Beam tunnels are used al-
most exclusively to transfer tubs
with pre-sterilized ready-to-use
Dr. Birte Scharf Varadharaj Vijayakumar
containers from Grade C to Grade A
Dr. Birte Scharf has 9 years of pharmaceutical Varadharaj Vijayakumar is an experienced pharma
areas. This method is not used for background and 3 years working experience in professional (14+ Years), diligent in his core
transfer of monitoring materials, aseptic processing technologies. She combined her functional area (Aseptic Fill Finish operations) and
passion for science and technology through wor- committed to the profession. His main area of
tools, and format parts.
king for Franz Ziel GmbH, a manufacturer of isola- expertise is aseptic processing, sterility assurance,
• No-Touch Transfer (NTT): NTT is an tor technology and GMP compliance service pro- lyophilization and resolution of complex techni-
alternative approach to transfer vider. As a Senior scientist in GMP Compliance cal/regulatory/GMP issues. He has also handled
Team she focusses on GMP-compliant process in- many regulatory audits and led team with
pre-sterilized tubs and trays of
tegration and on science and compliance of R&D successful audits. He is a registered pharmacist
ready-to-use containers from projects at Franz Ziel. She received her PhD in and Postgraduate in Pharmacy and an active
Grade C to Grade A. This method is pharmaceutical Biology working on treatments member of professional associations like PDA,
against uropathogenic E. coli at the University of TBM, Lyophilization World. In addition, he also
not suitable for monitoring materi-
Muenster. publishes technical articles and teaches young
als, tools, and format parts. learners from universities.
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